practical guide to clinical data management third edition

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Practical Guide To Clinical Data Management Third Edition

Author : Susanne Prokscha
ISBN : 9781439848296
Genre : Computers
File Size : 74. 76 MB
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The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then, the third edition of Practical Guide to Clinical Data Management includes important updates to all chapters to reflect the current industry approach to using electronic data capture (EDC) for most studies. See what’s new in the Third Edition: A chapter on the clinical trial process that explains the high level flow of a clinical trial from creation of the protocol through the study lock and provides the context for the clinical data management activities that follow Reorganized content reflects an industry trend that divides training and standard operating procedures for clinical data management into the categories of study startup, study conduct, and study closeout Coverage of current industry and Food and Drug Administration (FDA) approaches and concerns The book provides a comprehensive overview of the tasks involved in clinical data management and the computer systems used to perform those tasks. It also details the context of regulations that guide how those systems are used and how those regulations are applied to their installation and maintenance. Keeping the coverage practical rather than academic, the author hones in on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview or introduction for clinical data managers.

Practical Guide To Clinical Data Management

Author : Susanne Prokscha
ISBN : 1574910434
Genre : Medical
File Size : 54. 20 MB
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Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. And clinical data manages have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers you through a basic understanding of the role of data management in clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance. This book helps you ensure GCP, manage laboratory data, and deal with the kinds of clinical data that can cause difficulties in database applications. With the tools this book provides, you'll learn how to: Ensure that your DMB system is in compliance with federal regulations Build a strategic data management and databsing plan Track and record CRFs Deal with problem data, adverse event data, and legacy data Manage and store lab data Identify and manage discrepancies Ensure quality control over reports Choose a CDM system that is right for your company Create and implement a system validation plan and process Set up and enforce data collection standards Develop test plans and change control systems This book is your guide to finding the most successful and practical options for effective clinical data management.

General Pharmacology

Author : A. Heffter
ISBN : 3662320959
Genre : Medical
File Size : 54. 40 MB
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Medical Data Management

Author : Florian Leiner
ISBN : 9780387217734
Genre : Medical
File Size : 52. 80 MB
Format : PDF
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Medical Data Management is a systematic introduction to the basic methodology of professional clinical data management. It emphasizes generic methods of medical documentation applicable to such diverse tasks as the electronic patient record, maintaining a clinical trials database, and building a tumor registry. This book is for all students in medical informatics and health information management, and it is ideal for both the undergraduate and the graduate levels. The book also guides professionals in the design and use of clinical information systems in various health care settings. It is an invaluable resource for all health care professionals involved in designing, assessing, adapting, or using clinical data management systems in hospitals, outpatient clinics, study centers, health plans, etc. The book combines a consistent theoretical foundation of medical documentation methods outlining their practical applicability in real clinical data management systems. Two new chapters detail hospital information systems and clinical trials. There is a focus on the international classification of diseases (ICD-9 and -10) systems, as well as a discussion on the difference between the two codes. All chapters feature exercises, bullet points, and a summary to provide the reader with essential points to remember. New to the Third Edition is a comprehensive section comprised of a combined Thesaurus and Glossary which aims to clarify the unclear and sometimes inconsistent terminology surrounding the topic.

Data Mining

Author : Ian H. Witten
ISBN : 3446215336
Genre :
File Size : 87. 83 MB
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New Drug Development

Author : J. Rick Turner
ISBN : 9780470073735
Genre : Mathematics
File Size : 44. 26 MB
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This book acquaints students and practitioners in the related fields of pharmaceutical sciences, clinical trials, and evidence-based medicine with the necessary study design concepts and statistical practices to allow them to understand how drug developers plan and evaluate their drug development. Two goals of the book are to make the material accessible to readers with minimal background in research and to be straightforward enough for self-taught purposes. By bringing the topic from the early discovery phase to clinical trials and medical practice, the book provides an indispensable overview of an otherwise confusing and fragmented set of topics. The author’s experience as a respected scientist, teacher of statistics, and one who has worked in the clinical trials arena makes him well suited to write such a treatise.

Leading Change

Author : John P. Kotter
ISBN : 9783800646159
Genre : Fiction
File Size : 53. 97 MB
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John P. Kotters wegweisendes Werk Leading Change erschien 1996 und zählt heute zu den wichtigsten Managementbüchern überhaupt. Es wurde in zahlreiche Sprachen übersetzt und millionenfach verkauft. Der Druck auf Unternehmen, sich den permanent wandelnden internen und externen Einflüssen zu stellen, wird weiter zunehmen. Dabei gehört ein offener, aber professionell geführter Umgang mit Change-Prozessen zu den Wesensmerkmalen erfolgreicher Unternehmen im 21. Jahrhundert und zu den größten Herausforderungen in der Arbeit von Führungskräften. Einer der weltweit renommiertesten Experten auf diesem Gebiet hat basierend auf seinen Erfahrungen aus Forschung und Praxis einen visionären Text geschrieben, der zugleich inspirierend und gefüllt ist mit bedeutenden Implikationen für das Change-Management. Leading Change zeigt Ihnen, wie Sie Wandlungsprozesse in Unternehmen konsequent führen. Beginnend mit den Gründen, warum viele Unternehmen an Change-Prozessen scheitern, wird im Anschluss ein Acht-Stufen-Plan entwickelt, der Ihnen hilft, pragmatisch einen erfolgreichen Wandel zu gestalten. Wenn Sie wissen möchten, warum Ihre letzte Change-Initiative scheiterte, dann lesen Sie dieses Buch am besten gleich, sodass Ihr nächstes Projekt von Erfolg gekrönt wird. Ralf Dobelli, getabstract.com Leading Change is simply the best single work I have seen on strategy implementation. William C. Finnie, Editor-in-Chief Strategy & Leadership Leading Change ist ein weltweiter, zeitloser Bestseller. Werner Seidenschwarz, Seidenschwarz & Comp.

Elektrodermale Aktivit T

Author : Wolfram Boucsein
ISBN : 9783662069684
Genre : Psychology
File Size : 55. 39 MB
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Die Messung der elektrodermalen Aktivität stellt wohl die mit Abstand am häufigsten verwendete Methode zur Erfassung physiologischer Begleiterscheinungen psychischer Vorgänge dar. Mit dieser Monographie wird erstmals eine Gesamtdarstellung vorgelegt: in ihr sind die anatomischen, physiologischen, physikalischen und psychologischen Grundlagen integriert, die Methodik sowie - einführungsartig - die Verwendung elektrodermaler Meßtechniken in den wichtigsten Anwendungsbereichen der beteiligten Disziplinen beschrieben. Das Buch ist als Standardwerk anzusehen. Es informiert über zentrale und periphere Mechanismen der elektrodermalen Aktivität sowie entsprechenden Modellvorstellungen. Es vermittelt die Grundlagen der Meßtechniken, die Methoden der Erfassung, Registrierung und Weiterverarbeitung elektrodermaler Phänomene. Der Methodenteil ist mit konkreten Anleitungen versehen und wird durch einen Beitrag von E. Thom zur computerunterstützten Auswertung ergänzt. Der umfangreiche Anwendungsteil behandelt schwerpunktmäßig die Gebiete der allgemeinen, differentiellen und klinischen Psychophysiologie, zusätzlich arbeitspsychologische und forensische Anwendungen. Auch auf die Einsatzmöglichkeiten in der Neurologie, Psychiatrie, Dermatologie und inneren Medizin wird eingegangen.

Oncology Clinical Trials

Author : Susan Halabi, PhD
ISBN : 1935281763
Genre : Medical
File Size : 26. 30 MB
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Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout

Aufmerksamkeit Und Motorisches Lernen

Author : Gabriele Wulf
ISBN : 3437487108
Genre : Motorisches Lernen - Aufmerksamkeit
File Size : 73. 76 MB
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